Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.

Very Preterm Maturity of Infant Clinical Trial

Official title:

Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949788
• Other study ID #: ShenzhenBMCHH
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Shenzhen Bao'an Maternal and Child Health Hospital
• Contact: Jun Luo, M.D.
• Phone: +86-015818671195
• Email: luojun-78[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.

Description:

The rescue treatment of very low birth weight (VLBW) infants is the main task of our neonatal intensive care unit (NICU) is this era. Anemia of prematurity (AOP) is one of the most common complication of these infants, which can affect their growth, intelligence, behavior, immunity and hemodynamics, and even endanger their lives in severe situation. It is of great significance to investigate the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life for improving the prognosis of these infants.

Patient Registry procedures: First, the list of VLBW infants was obtained through medical record search, and sent to the principal investigator (PI) at each center when an infant was eligible for enrollment. Second, patients are included in this study according to the exclusion criteria by PI. Finally, the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection.

Statistical analysis:The two groups were compared by a Χ2-test for categorical variables, Mann-Whitney U Test were used when reporting medians.A P value of <0.05 was considered statistically significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

• Preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to NICU are eligible for the trial.

• Anemia was defined as a central venous hemoglobin harvested in the first 3 days of life less than two standard deviations below the mean for postnatal age.

Exclusion Criteria:

• Asphyxia (arterial pH <7.0, fifth minute Apgar score <3),

• Twin-to twin-transfusion syndrome,

• Discordant twins (difference in birth weight >20%),

• Major congenital anomalies or chromosomal anomalies,

• Disagree of parents.

Related Conditions & MeSH terms

• Anemia
• Very Preterm Maturity of Infant

Intervention

Other:
• No intervention
Retrospect study, no direct intervention

Locations

Country	Name	City	State
China	Shenzhen Bao'an Maternal and Child Health Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Bao'an Maternal and Child Health Hospital	Longhua Hospital Of Baoan District, Shenzhen

Country where clinical trial is conducted

China, 

References & Publications (4)

Bellach L, Eigenschink M, Hassanein A, Savran D, Salzer U, Mullner EW, Repa A, Klebermass-Schrehof K, Wisgrill L, Giordano V, Berger A. Packed red blood cell transfusion in preterm infants. Lancet Haematol. 2022 Aug;9(8):e615-e626. doi: 10.1016/S2352-3026(22)00207-1. — View Citation

Everhart KC, Donevant SB, Iskersky VN, Wirth MD, Dail RB. Case Comparison of Preterm Infant Stability During Packed Red Blood Cell Transfusions. Nurs Res. 2023 Jul-Aug 01;72(4):301-309. doi: 10.1097/NNR.0000000000000658. — View Citation

Nesterenko TH, Baliga N, Swaintek S, Abdelatif D, Aly H, Mohamed MA. The impact of a multifaceted quality improvement program on the incidence of necrotizing enterocolitis in very low birth weight infants. Pediatr Neonatol. 2022 Mar;63(2):181-187. doi: 10.1016/j.pedneo.2021.10.002. Epub 2021 Dec 5. — View Citation

Patel RM, Knezevic A, Shenvi N, Hinkes M, Keene S, Roback JD, Easley KA, Josephson CD. Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis in Very Low-Birth-Weight Infants. JAMA. 2016 Mar 1;315(9):889-97. doi: 10.1001/jama.2016.1204. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia of prematurity (AOP) development in very low birth weight (VLBW) infants	The incidence of AOP in the first 72 hours of life in VLBW infants	Through study completion, an average of three months
Secondary	Risk factor of AOP among VLBW infants	The maternal hemoglobin (Hb) levels before birth among VLBW infants with AOP and without.	Through study completion, an average of three months
Secondary	Mortality or Bronchopulmonary Dysplasia (BPD) among VLBW infants with AOP	The incidence of death or BPD among VLBW infants with AOP and without.	Through study completion, an average of three months